Efficacy of levofloxacin, omeprazole, nitazoxanide, and doxycycline (LOAD) regimen compared with standard triple therapy to eradicate Helicobacter pylori infection: a prospective randomized study from a tertiary hospital in India.

AIM: In this study, the efficacy of 14-day triple therapy was compared with that of a novel ten-day LOAD regimen to eradicate Helicobacter pylori infection in India. BACKGROUND: Helicobacter pylorus infection is widespread in India. Resistance to antibiotics commonly used against Helicobacter pylori is increasing rapidly, leading to traditional triple therapy's lower success. Therefore, a search for a new regimen is needed. METHODS: In this randomized trial, patients with Helicobacter pylori infection were randomized to a group receiving LOAD therapy (levofloxacin 250 mg OD, omeprazole 40 mg BD, nitazoxanide 500 mg BD, and doxycycline 100 mg OD) for ten days or a group receiving standard triple therapy (pantoprazole 80 mg, amoxicillin 2000 mg, and clarithromycin 1000 mg daily) in divided doses for 14 days). Gastric biopsy/RUT was done 10-12 weeks after completing therapy to confirm Helicobacter pylori eradication. RESULTS: Eradication rates were significantly greater with the LOAD regimen than with standard triple therapy on both intention-to-treat analysis (82.75% vs. 60.26%, p = 0.001; difference, 22.49% [95% CI, 8.5-18%] and per-protocol analysis (83.3% vs. 62.75%, p = 0.002; difference, 20.55% [95% CI, 7.1-22.5%]). Both treatment regimens were well tolerated. CONCLUSION: Although the rate of eradication of H. pylori infection was significantly higher with the LOAD regimen than triple therapy, the efficacy was still suboptimal, possibly because of fluoroquinolone resistance or the short course of treatment.

Is endoscopist-directed sedation for endoscopic retrograde cholangiopancreatography with balanced propofol solution (BPS) practical and safe? A prospective study from a tertiary care centre in India.

INTRODUCTION: Endoscopist-directed, nurse-administered sedation using propofol, midazolam, and fentanyl for endoscopic retrograde cholangiopancreatography (ERCP) is being utilized worldwide. However, this is not usually employed in India by endoscopists. AIM: To assess the efficacy, acceptability, and safety of this sedation in low to moderate risk patients undergoing ERCP. MATERIAL AND METHODS: This was a prospective study involving 500 patients with any indication for ERCP. The sedation was given by trained nurses. RESULTS: The sedative dosages per patient were as follows: propofol = 90 ±20 mg, fentanyl 0.75 ±0.25 mg (range: 0.25-1.00 mg), and midazolam 2 ±0.5 mg (range: 1-3 mg). Ninety-seven percent of patients achieved Richmond agitation sedation score of ≥ -3, and 96.8% achieved Gloucester comfort score of ≤ 2. 4.22% of the patients had mild adverse events (AE), and 2.11% had moderate AE. Two (0.4%) patients required intubation and intensive care unit admission. Mean recovery time was 15.3 min. 98.3% of the endoscopists were satisfied with the sedation achieved. 31.2% of the patients remembered the procedure. 93% of the patients were satisfied with the type of sedation. 92.75% of ERCPs were successful. 7.59% had procedure-related complications: in the form PEP - 5.290%, significant bleeding - 1.08%, and perforation - 0.43%. CONCLUSIONS: Endoscopist-directed, nurse-administered sedation for ERCP with balanced propofol solution is practical, efficient, time saving, safe, and acceptable to patients.

Differentiating secondary from primary dengue using IgG to IgM ratio in early dengue: an observational hospital based clinico-serological study from North India.

BACKGROUND: Secondary dengue causes more severe disease than the primary. Early on, it is important to differentiate the two. We tried to find important clinical and laboratory differences between the two for the purpose of early differentiation. METHODS: One hundred fourteen patients confirmed on reverse transcriptase-polymerase chain reaction (RT PCR) were studied. On day 2 of illness IgM and IgG indices were studied for calculation of IgG/IgM ratio. A one-step immunochromatographic assay was used for classification of patients into primary and secondary dengue. Patient characteristics were also studied. RESULTS: Dengue serotype 1 was the most common found in 60.5% patients. 66.7% (76 patients) had secondary dengue. Secondary dengue cases had a higher mean temperature (101.56 ± 1.55 vs. 100.79 ± 1.25,°F, p 0.015), lower platelet counts (50.51 ± 38.91 vs. 100.45 ± 38.66, x 103/micl, p <0.0001) and a significantly higher percentage of Dengue hemorrhagic fever/Dengue shock syndrome (38.2% vs. 2.6%, p <0.0001). In early phase of dengue NS1 and PCR were found to be better tests for diagnosis and later IgM is better. The IgG/IgM ratio of ≥ 1.10 had a sensitivity of 100%, specificity of 97.4% and accuracy of 67.5% in differentiating secondary from primary dengue. CONCLUSION: Early on in the clinical course, IgG/ IgM ratio can play an important role to differentiate the two. We found the ratio of ≥ 1.10 to be the best cut off for the same.

Association of Helicobacter pylori with hepatobiliary stone disease, a prospective case control study.

BACKGROUND: Hepatobiliary stone disease is one of the most common surgical conditions worldwide. There are multiple causative agents responsible for the formation of hepatobiliary stones, and bacterial infection is one of them. The presence of Helicobacter DNA species has been investigated in the biliary epithelium of patients with biliary diseases. However, conflicting results have been observed that may have been due to the small number of subjects studied, difficulty in obtaining a healthy control group, absence of controlling for confounding factors, or ethical and regional differences among populations. METHODS: We investigated the presence of Helicobacter pylori species by PCR of 26-kDa surface antigen specific to H. pylori in bile samples from 50 cases with hepatobiliary stones and 25 controls without hepatobiliary stones. The control group comprised of 20 patients of hydatid cyst disease of liver and 5 patients of right colonic growth. RESULT: H. pylori was present in 20 bile samples among cases and was absent in 30 bile samples among cases. Among controls, H. pylori could not be detected. A significant association of the presence of H. pylori with hepatobiliary stone disease was seen (p < 0.001). CONCLUSION: There is an association between bile infection with H. pylori and hepatobiliary stone disease.

Association of Low Levels of Vitamin D with Chronic Stable Angina: A Prospective Case-Control Study.

BACKGROUND: Coronary artery disease (CAD) is a major cause of death and disability in developed countries. Chronic stable angina is the initial manifestation of CAD in approximately 50% of the patients. Recent evidence suggests that vitamin D is crucial for cardiovascular health. The prevalence of vitamin D deficiency in our region is 83%. A low level of vitamin D is associated with chronic stable angina. AIM: This study was aimed at supporting or refuting this hypothesis in our population. MATERIALS AND METHODS: The study was a prospective case-control study. We studied 100 cases of chronic stable angina and compared them with 100 matched controls. Vitamin D deficiency was defined as <20 ng/mL, vitamin D insufficiency as 20-30 ng/mL and normal vitamin D level as 31-150 ng/mL. RESULTS: The prevalence of vitamin D deficiency among cases and controls was 75% and 10%, respectively. 75% of the cases were vitamin D-deficient (<20 ng/mL); 12% were vitamin D-insufficient (20-30 ng/mL), and 13% had normal vitamin D levels (31-150 ng/mL). None had a toxic level of vitamin D. Among the controls, 10% were vitamin D-deficient, 33% were vitamin D-insufficient, and 57% had normal vitamin D levels. The mean vitamin level among cases and controls was 15.53 ng/mL and 40.95 ng/mL, respectively, with the difference being statistically significant (P ≤ 0.0001). There was no statistically significant relation between the disease severities, i.e., on coronary angiography (CAG) with vitamin D level. Among the cases, we found that an increasing age was inversely related to vitamin D levels (P = 0.027). CONCLUSION: Our study indicates a correlation between vitamin D deficiency and chronic stable angina. Low levels may be an independent, potentially modifiable cardiovascular risk factor.

Assessment of Correlation between Sweat Chloride Levels and Clinical Features of Cystic Fibrosis Patients.

INTRODUCTION: Cystic Fibrosis (CF) is an autosomal recessive disorder and the incidence of this disease is undermined in Northern India. The distinguishable salty character of the sweat belonging to individuals suffering from CF makes sweat chloride estimation essential for diagnosis of CF disease. AIM: The aim of this prospective study was to elucidate the relationship of sweat chloride levels with clinical features and pattern of CF. MATERIALS AND METHODS: A total of 182 patients, with clinical features of CF were included in this study for quantitative measurement of sweat chloride. Sweat stimulation and collection involved pilocarpine iontophoresis based on the Gibson and Cooks methodology. The quantitative estimation of chloride was done by Schales and Schales method with some modifications. Cystic Fibrosis Trans Membrane Conductance Regulator (CFTR) mutation status was recorded in case of patients with borderline sweat chloride levels to correlate the results and for follow-up. RESULTS: Out of 182 patients having clinical features consistent with CF, borderline and elevated sweat chloride levels were present in 9 (5%) and 41 (22.5%) subjects respectively. Elevated sweat chloride levels were significantly associated with wheeze, Failure To Thrive (FTT), history of CF in Siblings, product of Consanguineous Marriage (CM), digital clubbing and steatorrhoea on univariate analysis. On multivariate analysis only wheeze, FTT and steatorrhoea were found to be significantly associated with elevated sweat chloride levels (p<0.05). Among the nine borderline cases six cases were positive for at least two CFTR mutations and rest of the three cases were not having any mutation in CFTR gene. CONCLUSION: The diagnosis is often delayed and the disease is advanced in most patients at the time of diagnosis. Sweat testing is a gold standard for diagnosis of CF patients as genetic mutation profile being heterozygous and unlikely to become diagnostic test.